A guide to RoHS Directive (2011/65/EU)
If you sell anything with a plug, a battery or a circuit board in the EU, RoHS applies to you. It is one of the shortest pieces of EU product law and one of the most frequently misunderstood, mainly because the limits work in a way that is not obvious.
This guide covers what RoHS restricts, which products are in and out of scope, what manufacturers, importers and distributors have to do, how compliance is proved in practice, and what has changed recently.
What RoHS is
RoHS stands for Restriction of Hazardous Substances. The Directive limits ten substances in electrical and electronic equipment (EEE) sold in the EU. The aim is to keep toxic materials out of landfill and recycling streams and to protect the people who make, repair and recycle electronics.
RoHS is a CE marking directive. A product in scope must carry the CE mark, and the EU Declaration of Conformity must cite 2011/65/EU alongside any other directives that apply, such as the Low Voltage Directive or the Radio Equipment Directive.
RoHS 1, RoHS 2 and RoHS 3
RoHS 1 (2002/95/EC)
Applied from 1 July 2006 and restricted six substances: lead, mercury, cadmium, hexavalent chromium, PBB and PBDE. It had no CE marking or Declaration of Conformity requirement, which is why many manufacturers invented their own “RoHS compliant” logos and certificates in that period.
RoHS 2 (2011/65/EU)
Replaced it from 3 January 2013. It kept the same six substances but brought RoHS into the CE marking system, added formal obligations for manufacturers, importers and distributors, and widened the scope in stages until it became “open scope” on 22 July 2019, covering all EEE unless specifically excluded.
RoHS 3
Is the informal name for Delegated Directive (EU) 2015/863, which added four phthalates to the restricted list. The phthalate limits have applied since 22 July 2019 for most products, and since 22 July 2021 for medical devices and monitoring and control instruments.
The current law is still Directive 2011/65/EU, as amended. There is no separate “RoHS 3 Directive”.
How to know if you’re RoHS compliant?
When a company wants to know if they are compliant with the European Union RoHS Directive, the first thing that needs checking is which substances have been restricted by this law. This will allow you as an individual or business owner time to research your specific needs without getting caught up in something inappropriate like lead-based paint.
The ten restricted substances and their limits
| Substance | Maximum concentration |
|---|---|
| Lead (Pb) | 0.1% |
| Mercury (Hg) | 0.1% |
| Cadmium (Cd) | 0.01% |
| Hexavalent chromium (Cr VI) | 0.1% |
| Polybrominated biphenyls (PBB) | 0.1% |
| Polybrominated diphenyl ethers (PBDE) | 0.1% |
| Bis(2-ethylhexyl) phthalate (DEHP) | 0.1% |
| Butyl benzyl phthalate (BBP) | 0.1% |
| Dibutyl phthalate (DBP) | 0.1% |
| Diisobutyl phthalate (DIBP) | 0.1% |
0.1% is 1,000 parts per million. Cadmium’s limit of 0.01% is 100 parts per million, ten times stricter than the rest.
The limits apply per homogeneous material, not per product
This is the point most sellers miss. The percentages are measured in each homogeneous material, which the Directive defines as a material of uniform composition that cannot be mechanically separated into different materials. The solder on a circuit board is one homogeneous material. The plastic housing is another. The plating on a connector pin is a third.
So a product weighing a kilogram is not allowed one gram of lead spread around. Each individual material, however small, must be under the limit on its own. A single leaded solder joint puts the whole product out of compliance unless an exemption covers it.
Which products are in scope
Since 22 July 2019 RoHS covers all EEE, defined as equipment that depends on electric current or electromagnetic fields to work, or that generates, transfers or measures them, rated up to 1,000 V AC or 1,500 V DC. Annex I groups this into eleven categories:
- Large household appliances
- Small household appliances
- IT and telecommunications equipment
- Consumer equipment
- Lighting equipment
- Electrical and electronic tools
- Toys, leisure and sports equipment
- Medical devices
- Monitoring and control instruments, including industrial ones
- Automatic dispensers
- Other EEE not covered by the categories above
Category 11 is the catch-all. If a product needs electricity for at least one intended function and is not on the exclusion list, RoHS applies. Cables and spare parts for in-scope products are also covered.
Several types of products are also excluded from the RoHS Directive
Article 2 excludes the following from RoHS:
- Equipment for essential security interests, including arms and munitions for military use
- Equipment designed to be sent into space
- Equipment specifically designed to be installed as part of another type of excluded equipment, which can only work as part of it
- Large-scale stationary industrial tools
- Large-scale fixed installations
- Means of transport for people or goods, apart from electric two-wheelers that are not type-approved
- Non-road mobile machinery for professional use only
- Active implantable medical devices
- Photovoltaic panels intended for permanent installation at a defined location by professionals
- Equipment made for research and development only and supplied business to business
- Pipe organs
Everything else with electronics is in.
Batteries are separate
Batteries and accumulators inside EEE are not regulated by RoHS. They fall under the Batteries Regulation (EU) 2023/1542, which has its own substance limits for mercury, cadmium and lead. The equipment around the battery is still RoHS.
Exemptions
Some uses of restricted substances have no workable alternative yet, so the Directive allows exemptions. Annex III lists general exemptions, such as lead in high melting temperature solders, lead in certain glass and ceramic components, and lead as an alloying element in steel, aluminium and copper. Annex IV lists exemptions specific to medical devices and monitoring and control instruments.
Exemptions are temporary. They last up to five years for most categories and up to seven for medical and monitoring equipment, and must be renewed on application. Several lead exemptions were renewed with revised wording and new expiry dates in 2025. If your product relies on one, your technical documentation should say which one and you should track its expiry.
Obligations of manufacturers
Design and manufacture the product so every homogeneous material is under the limits or covered by an exemption. Carry out internal production control (Module A; no notified body is needed). Draw up the technical documentation and the EU Declaration of Conformity, and apply the CE mark. Keep the documentation for ten years after the last unit is placed on the market. Make sure series production stays compliant, including when component suppliers change. Mark the product with a type, batch or serial number and with your name and address. Take corrective action, and inform the authorities, if a non-compliant product has been sold.
Obligations of authorised representatives
A manufacturer outside the EU can appoint an EU based authorised representative by written mandate. The representative keeps the Declaration of Conformity and technical documentation available for ten years, provides them to market surveillance authorities on request, and cooperates on any corrective action. The representative cannot take over the design and manufacturing obligations themselves.
Obligations of importers
Only place compliant EEE on the market. Check that the manufacturer has done the conformity assessment, that the technical documentation exists, that the CE mark is on the product and that the manufacturer’s name and address are shown. Add your own name and address to the product or packaging. Keep a copy of the Declaration of Conformity for ten years and make the technical documentation available on request. Inform the manufacturer and the authorities if you find a non-compliance.
Obligations of distributors
When it comes to the EU market, many different people make electrical and electronic equipment available. A distributor can be anyone that sells these products- whether they’re a wholesaler or retailer of some kind! The legal obligations for RoHS regulations among distributors are as follows:
- To ensure that your products comply with all applicable regulations, it is essential to verify the CE mark affixation on them and their type and batch/serial number. It would be best to make sure any required documentation accompanies these items when exporting or importing goods into another country for sale–good practice would be to use software like welding EDR, which can help you do this quickly and easily.
- To make sure the product is safe, you must verify that its manufacturer’s trade name or trademark and address are on it as well. If an importer has been associated with importing goods into your country, they should also be able to provide proof of ownership for this information!
- The company has to withdraw or recall any non-compliant products already placed on the European Union market.
- Inform the national authorities and manufacturer or importer of any non-compliance.
- The company has a strict policy to ensure that any equipment that is not compliant with RoHS regulations will be disposed of immediately.
- It is critical to comply with national authorities’ requests for information when the product’s compliance status is in question to avoid unnecessary delays and costs.
When an importer or distributor becomes the manufacturer
Under Article 11, an importer or distributor takes on all manufacturer obligations if it sells the product under its own name or trademark, or modifies a product in a way that could affect compliance. For private label sellers on Amazon this is the normal position: if it is your brand, you are the manufacturer in law, wherever the factory is.
How compliance is proved in practice
RoHS does not require every product to be tested in a lab. It requires you to be able to show, with documents, that each material is compliant. The harmonised standard for this is EN IEC 63000:2018, which sets out how to build the technical documentation from a mix of:
Supplier material declarations for each component, stating RoHS status and any exemptions used. Bills of materials that map declarations to parts. Analytical test reports where risk is higher or supplier evidence is weak, using the IEC 62321 test methods. XRF screening is common for a first pass; wet chemistry follows for anything borderline. Records of how supplier changes are checked.
A “RoHS certificate” from a factory is not, on its own, enough. Market surveillance authorities and Amazon compliance teams want to see the Declaration of Conformity citing 2011/65/EU, and the evidence behind it.
RoHS and REACH
RoHS and REACH both apply to electronics, and they do different jobs. RoHS restricts ten substances in EEE. REACH (Regulation 1907/2006) applies to almost all articles, EEE included, and adds its own restrictions in Annex XVII, plus duties around Substances of Very High Concern: notifying ECHA above 0.1% and telling customers on request. A compliant electronic product meets both. The phthalates are a good example. DEHP, BBP, DBP and DIBP are limited under RoHS in the EEE itself and under REACH in the packaging and accessories around it.
The UK position
Great Britain applies the same substance limits under the RoHS Regulations 2012 (SI 2012/3032), with the UKCA mark and a UK Declaration of Conformity. The UK Government has confirmed it will recognise CE marking indefinitely for products under the RoHS regulations, so a CE marked product with an EU Declaration of Conformity can be sold in Great Britain without re-marking. Northern Ireland follows the EU Directive. Non-UK manufacturers still need a UK based authorised representative or importer whose details appear on the product.
Penalties
Penalties are set nationally, and Member States are required to make them effective, proportionate and dissuasive. In practice enforcement means product withdrawal or recall notices, fines that vary by country, and, for online sellers, marketplace listing removal, which is often the first sign a seller has of a problem.
What is changing
Evaluation, not recast. The European Commission completed its review of RoHS in December 2023 and concluded that the Directive remains relevant and should be improved rather than replaced. There is no plan to fold it into another act.
ECHA takes over the technical work. Directive (EU) 2025/2456, published on 12 December 2025, moves the scientific and technical tasks under RoHS to the European Chemicals Agency as part of the “one substance, one assessment” reform. From 13 August 2027 ECHA prepares dossiers for new substance restrictions and reviews the restricted list at least every four years. From 27 August 2027 exemption applications go to ECHA rather than the Commission, with fixed timelines for completeness checks and opinions. For sellers the substance limits do not change, but the pace of restriction and exemption decisions is expected to pick up.
Exemption renewals. Three delegated directives in 2025 renewed and narrowed the lead exemptions for alloys, high temperature solders and glass or ceramic components. Check any exemption you rely on against the current Annex III text.
Conclusion
RoHS is simple to state and easy to get wrong. Ten substances, two limits, measured material by material, across almost every electrical product on the market. The proof sits in your technical documentation, and the CE mark and Declaration of Conformity are only as good as the supplier declarations and test reports behind them.
Euverify helps non-EU electronics brands put that documentation together, acts as EU and UK authorised representative, and prepares the EU and UK Declarations of Conformity that Amazon and the authorities ask for. If you are not sure your RoHS file would hold up, we are happy to take a look.
Sources: Directive 2011/65/EU (consolidated text, EUR-Lex); Delegated Directive (EU) 2015/863; Directive (EU) 2025/2456; European Commission, RoHS Directive page (environment.ec.europa.eu); EN IEC 63000:2018.
